510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+10K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+10K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+10K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+10K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+10K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+10K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+10K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+11K261279DeltaNEC Interbody SystemNexus Spine20260—
+11K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K240699SCARLET® AC-TiSpineart SA20240—
+11K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+11K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+11K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+11K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+11K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+11K223326Axiom PSR SystemRestor3D202301
+11K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+12K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+12K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402